Life Science Compliance Update

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November 30, 2017

ACCME Introduces Guidance for CME Providers on MEDTECH, APACMed and China Codes

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Recently, MedTech Europe, the Advanced Medical Technology Association (AdvaMed), and the Asia Pacific Medical Technology Association (APACMed) introduced changes to their respective codes of conduct relating to professional development activities, including continuing medical education (CME). As such, the Accreditation Council for Continuing Medical Education (ACCME) has offered guidance for CME providers with respect to the changes.  

Starting in 2018, it is expected that the revised codes will require member manufacturers to discontinue making direct payments to clinicians to fund their attendance at professional development activities. However, the manufacturers may continue to support the engagement of physicians in professional development and CME activities through grants that are given to health systems and employers, and through grants to accredited CME providers.  

Following the longstanding procedure, organizations that are accredited in the ACCME system may accept financial support for their educational activities from commercial entities (I.e., device manufacturers) under the revised codes and maintain independence from industry by following ACCME's Standard 3: Appropriate Use of Commercial Support.  

Standard 3 can be met by an accredited organization following the below criteria when accepting funding from commercial interests: 

  • Make all decisions regarding the use of the support, independent of any company or companies; 
  • Have a signed written agreement with the company that includes the specific terms and conditions of the support; 
  • Use the funds only for the educational activity and to offset the cost of participation to the learners as a whole;  
  • Not pay for travel, lodging, honoraria, or personal expenses for any non-teacher or non-author participants of the supported educational activity; and 
  • Disclose to all learners the source (and if in-kind, the nature) of the commercial support.  

The revised codes and ACCME requirements can be aligned together by ensuring that funds received from companies by organizations accredited in the ACCME system are not used to pay for any travel, lodging, honoraria, or personal expenses for any non-teacher or non-author participants. This ensures the accredited organization does not act as an intermediary to establish a relationship between an ACCME-defined commercial interest and the learners in an accredited activity, as well as helping to ensure clinicians' prescribing or device usage patterns are not inappropriately influenced.  

If an international learner receives funding from his or her hospital or other commercial entity not affiliated with the ACCME-accredited organization to participate in the education, the accredited organization is not prohibited from accepting that learner's registration and participation in the education.  

In a press release announcing the changes and the ACCME guidance, ACCME applauded the change, "since they bring industry standards in closer alignment with those that have existed here in the United States since 1992, and in doing so support greater transparency and independence in global medical education. ACCME also noted that the standards and principles in the revised codes are aligned even with the ACCME's own Standards for Commercial Support, which have been internationally recognized as a benchmark for independent medical education and adopted by other healthcare continuing education accreditors throughout the world.  

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